Industry Roundup: Nicotine Exposure ANPR, Athena Petition Denied
This article was originally published in The Tan Sheet
Executive Summary
Comments sought for nicotine-exposure ANPR; Supreme Court denies Athena petition; Neuragen U.S. market rights; Prestige ‘TMI’ about Monistat; and more news in brief.
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Amarin Not Giving Up On Omega-3 Trade Battle
Amarin asks Federal Circuit Court to direct US ITC to investigate its complaint that some omega-3 ingredients are unapproved drugs. Company questions FDA's request for policy deference given resource constraints and says Supreme Court rulings show compliance with FDA regulations in cosmetic and food labeling does not preclude litigation alleging the information renders a product an unapproved drug or represents false advertising.
Amarin Not Giving Up On Omega-3 Trade Battle
Amarin asks Federal Circuit Court to direct US ITC to investigate its complaint that some omega-3 ingredients are unapproved drugs. Company questions FDA's request for policy deference given resource constraints and says Supreme Court rulings show compliance with FDA regulations in cosmetic and food labeling does not preclude litigation alleging the information renders a product an unapproved drug or represents false advertising.
Athena Appeal Decision Could Open ‘Floodgate’ For False Claims Litigation
Lower court decisions that Athena Cosmetics’ RevitaLash products is an unapproved drug competing unfairly against Allergan's Latisse drug could have broader implications if the Supreme Court denies the firm's request for review. Already beleaguered by class actions following FDA warnings, firms could face more opportunistic lawsuits if federal courts are left to determine a product's intended use and regulatory status.